Clinical Trial Details

Overview

Research Study Summary

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease

Purpose

The name of this trial is MissionAD2. This 24-month treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat (proposed international nonproprietary name [pINN]) (E2609).

To Learn more

CW ID: 224779
Date Last Changed: June 7, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
N/A
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Inclusion Criteria:

Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including:
  1. Mini Mental State Examination score equal to or greater than 24
  2. Clinical Dementia Rating (CDR) global score of 0.5
  3. CDR Memory Box score of 0.5 or greater
  4. Impaired episodic memory confirmed by a list learning task
  5. Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography (PET) or cerebrospinal fluid assessment or both
  6. Study partner able to support the participant for duration of the study
Exclusion Criteria:
  1. Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation
  2. Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
  3. Participants with a history of seizures within 5 years of Screening
  4. History of transient ischemic attacks or stroke within 12 months of Screening
  5. Psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, delusions, etc.)
  6. Have any contraindications to magnetic resonance imaging (MRI) scannin
  7. Participants who have a history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
  8. Results of laboratory tests conducted during Screening that are outside the following limits
  9. Participants at risk of increased risk of infection
  10. Have received any live vaccine in the 3 months before randomization
  11. Any chronic inflammatory disease that is not adequately controlled or that requires systemic or ocular immunosuppressive or immunomodulatory therapy
  12. Any other clinically significant abnormalities
  13. Severe visual or hearing impairment
  14. A prolonged QTc interval (QTcF greater than 450 milliseconds [ms])
  15. Malignant neoplasms within 5 years of Screening
  16. Known or suspected history of drug or alcohol abuse
  17. Taking prohibited medications, which must be reviewed with the Investigator
  18. Have participated in a recent clinical study

Contact

Kaley Killdahl, Clinical Research Coordinator
APG Research, LLC
721 N.Magnolia Avenue
Orlando, FL 32803
Phone: (407) 423-7149 x165

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Research Center Information:

APG Research, LLC

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

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